Agricultural News
More Details Reported on FDA Weaknesses
Wed, 07 Apr 2010 17:38:29 CDTThe report, released by the Department of Health and Human Services Office of the Inspector General reveals that in fiscal year 2007, FDA took action against 46 percent of the facilities that initially received OAI classifications. FDA either lowered the classification or took no regulatory action for the remaining facilities. The report also indicates that most of the facilities that received OAI classifications had a history of violations and that some facilities refused to grant FDA access to their records.
Finally, for 36 percent of the facilities that received OAI classifications, FDA took no additional steps to ensure that the violations were corrected. For the remaining facilities, FDA either re-inspected the facilities or reviewed some type of evidence from the facility that demonstrated that the facility had corrected violations.
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